Methods for delivery of screws for joint fusion

ABSTRACT

Procedures for the fusion of the sacroiliac joint advantageously make use of an implant selected to distract the joint upon insertion and to maintain or increase tension upon insertion. The implant can have a varying structure along its length. In some method described herein for fusing the sacroiliac joint using an implant, an implant is screwed into the sacroiliac joint between the sacrum bone and the iliac bone. The implant comprises a shaft, a tool engagement flange at top end of the shaft, a pointed tip comprising no more than about 20 percent of the length of the screw, and threads spiraling around the shaft. For screws of particular interest, the volume displacement perpendicular to the shaft increases at least about 5 percent from a point adjacent the tip to a point near the top of the shaft. Some of the desirable screw designs can be used in other orthopedic application, especially situations involving varying bone hardness. Useful filler material can be formed from a blend of bone powder and bioactive agents.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of copending U.S. patent applicationSer. No. 14/149,197 filed Jan. 7, 2014 to Stark entitled “Methods forDelivery of Screws for Joint Fusion,” which is a continuation of U.S.application Ser. No. 12/651,843 to Stark, filed on Jan. 4, 2010,entitled “Bone Screws and Particular Applications to Sacroiliac JointFusion,” which is a continuation of U.S. application Ser. No. 11/879,536to Stark, filed on Jul. 17, 2007, entitled “Bone Screws and ParticularApplications to Sacroiliac Joint Fusion,” all of which are herebyincorporated by reference.

FIELD OF THE INVENTION

The invention relates to methods for fusing the sacroiliac joint usinganchors that distract the joint and immobilize the joint in itsdistracted position. The invention further relates to bone screw designsthat are versatile with respect to firm anchoring in softer or harderbone structures through increasing gripping of the structure as thescrew is advanced.

BACKGROUND OF THE INVENTION

Lower back pain is a common ailment among the population and results inpain and suffering as well as loss of work time. Thus, approaches forthe treatment of back pain can both relieve suffering as well as reduceemployee sick time. Since back pain results in considerable employeeabsenteeism, effective treatments for lower back pain have both economicbenefits as well as the benefit of alleviating considerable suffering.

The sacroiliac joint is located at the juncture of the ilium, the upperbone of the pelvis, and the sacrum at the base of the spine. While thesacroiliac joint has a limited range of motion, dysfunction of the jointhas been identified. The joint is supported by a range of ligamentsincluding, for example, the sacroiliac ligament at the base of the jointand the anterior sacroiliac ligament at the top of the joint. The jointis in the vicinity of the passage of a large number of blood vessels andnerves that pass from the torso to the lower extremities. Any proceduresnear the joint should avoid damage to the adjacent vessels and nerves.

SUMMARY OF THE INVENTION

In a first aspect, the invention pertains to a method for fusing thesacroiliac joint in which the method comprises drilling, selecting animplant and inserting the implant. In particular a bore is drilled intothe joint between the sacrum bone and iliac bone to prepare the jointfor insertion of an implant. A threaded implant is selected based on theprepared joint in which the implant or screw is selected to distract thejoint upon insertion and maintains or increases tension upon insertion.The implant can have a varying structure along its length. The selectedimplant can be inserted into the bore within the sacroiliac jointbetween the sacrum bone and iliac bone to immobilize the joint. In someembodiments, material is also placed into the joint or as a component ofthe implant to promote bone growth before, during or followingcompletion of the procedure to deliver an implant.

In further aspects, the invention pertains to a method for fusing thesacroiliac joint using an implant. The method can comprise screwing animplant into the sacroiliac joint between the sacrum bone and the iliacbone in which the implant comprises a shaft, a tool engagement flange attop end of the shaft, a pointed tip comprising no more than about 20percent of the length of the screw, and threads spiraling around theshaft. In some embodiments, the volume displacement of the threadsperpendicular to the shaft increases at least about 5 percent from apoint adjacent the tip to a point near the top of the shaft.

In additional aspects, the invention pertains to a medical implantablescrew comprising a headless shaft, a tool engagement flange at top endof the shaft, a pointed tip comprising no more than about 20 percent ofthe length of the screw, and threads spiraling around the shaft. In someembodiments, the volume displacement of the thread increases at leastabout 5 percent from a point adjacent the tip relative to a point nearthe top of the shaft and wherein the screw comprises one or morebiocompatible materials.

In other aspects, the invention pertains to a method for inducing bonein-growth for joint fusion or bone repair. The method comprises placinga blend of a bone powder alone or in combination with a bioactive agentthat induces bone growth into a joint or bone fracture. In someembodiment, the bioactive agent induces bone growth.

Furthermore, the invention pertains to a composition comprising a blendof bone powder and a bioactive agent that simulates bone growth.

In addition, the invention pertains to a method for selecting anorthopedic implant. The method comprises placing a sizing element into aprepared location for a bone screw and tightening the sizing elementwith a torque wrench to evaluate the size of appropriate bone screw forimplantation into the site.

In further aspects, the invention pertains to an orthopedic implantcomprising a bone replacement materials and a bone growth stimulatingbiologically active agent. The bone replacement material is abio-resorbable polymer, a natural or synthetic bone composition or acombination thereof. The biologically active agent generally is blendedinto the bone replacement material composition

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an embodiment of an implant having a head and apointed tip.

FIG. 2 is a top view of the implant of FIG. 1.

FIG. 3 is a side view of an implant core having an approximatelyconstant core diameter over the length of the implant.

FIG. 4 is a side view of a cannulated implant core having anapproximately constant core diameter in which the path of the corechannel is outlined with phantom lines.

FIG. 5 is a top view of the core of FIG. 4.

FIG. 6 is a side view of a hollow, fenestrated implant.

FIG. 7 is a side view of a headless implant with a tapered core.

FIG. 8 is a top view of the implant of FIG. 7.

FIG. 9 is a side view of an implant with a generally cylindrical coreand tapered threads.

FIG. 10 is side view of a tapered implant with a changing thread pitch.

FIG. 11 is a side view of a tapered implant with two sets of co-axialthreads.

FIG. 12 is a sectional view of the sacroiliac joint.

FIG. 13 is a side view of the sacroiliac joint with hidden vertebrae andthe sacroiliac joint shown in phantom lines.

FIG. 14 is a front view of a model of the sacroiliac joint exposed fromthe tissue with a drill bit positioned to drill a bore into the jointbetween the sacrum bone and the iliac bone.

FIG. 15 is a front view of a model of the sacroiliac joint exposed fromthe tissue with a screw positioned for placement into a bore drilledinto the joint between the sacrum bone and the iliac bone.

FIG. 16 is a side view depicting the sacroiliac joint with the implantand filler material inserted into the joint between the sacrum bone andiliac bone.

FIG. 17 is a sectional view through the sacroiliac joint showing theimplant placed into the joint.

DETAILED DESCRIPTION OF THE INVENTION

Improved fusion of the sacroiliac joint can be accomplished withimplants, e.g., screws that are designed to distract the joint withspreading forces as they are screwed into the joint. In particular, thesacroiliac joint can be successfully fused through the insertion of animplant directly into the gap of the joint between the iliac bone andsacral bone with the implant gripping bone on the respective sides ofthe joint. If the implant is designed properly to increase distractionof the joint as it is advanced into the joint, the implant can beselected to screw tightly into the joint to stably fuse the joint. Theplacement of the implant can be prepared through drilling, impacting orthe like. An implant can be selected that screws into the resulting boreand tightens with a desired amount of tension. In some embodiments, thethreads of the improved screws have threads that increase in volumedisplacement from the tip to the head to provide greater spreadingforces as the screw is inserted.

The sacroiliac joint has some properties that make the joint challengingfor fusion. Pioneering work has demonstrated that fusion of thesacroiliac joint using implants and the like placed into the jointbetween the sacrum bone and iliac bone can alleviate chronicdebilitating lower back pain where there is no other identifiablesource. While the sacroiliac joint does not move large distances, wear,damage and/or concentration of forces to the joint evidently can resultin intense pain. Due to the complexity of the joint, inaccessibility tothe joint surfaces and the major nerve and vascular structures passingadjacent the joint, the joint is not presently amenable to jointreplacement. Similarly, the joint is not amenable to revision,realignment or reconstruction. The joint is held together by a networkof ligaments that hold the joint together to resist distracting forces.

The sacroiliac joint generally can have significantly differing bonecharacteristics across the joint. At points where the load is carried,the bone can be hard while closely neighboring bone can be relativelysoft. Thus, a fusion procedure can encounter significantly differentbone on different occasions and even at different locations across theplacement of the implant during a single procedure. While the proceduresdescribed herein comprise identification of the boundaries of the joint,placement of the implant within the joint generally is selected withoutinformation on the character of the underlying bone since the locationsof the force load across the joint cannot be easily measured.

In some embodiments, design of improved screws for the immobilization ofthe sacroiliac joint can provide desirable screw configurations forgeneral bone screws. In particular, the screws can be selected toprovide good gripping whether or not the bone encountered is relativelyhard or relatively soft. For implantation into the sacroiliac joint, itis desirable for the bone to distract the joint through the direction ofspreading forces from the screw. Thus, in some embodiments, the screwcan be designed to have characteristics that differ at differentpositions along the length of the screw. For example, the distraction ofthe joint can increase as the screw is implanted into the joint. In someembodiments it is desirable to select the shape of the screw, e.g., thecore and/or the threads, such that the screw grips more strongly as thescrew is advanced. Other portions of the procedure, such as drilling andpost-implantation processing of the joint, can also be adapted for theimmobilization procedure to take better advantage of the procedure'sobjectives of distracting and stabilizing the joint.

In general, bone screws can be used to stabilize a crushed bonestructure, attached fractured bone elements to each other, attach anobject, such as a ligament or tendon, to a bone and/or immobilize a bonejoint. A considerable amount of development has been devoted to spinalscrews to stabilized crushed or damaged spinal disks. In spinalapplications, the purpose of a spine cage can be space filing. However,other applications generally can involve gripping by the screw based onspreading forces extending radially outward from the axis of the screw.A head on the screw may or may not be desired for facilitating transferof axial forces into spreading forces.

In order for the screw to grip more tightly as the screw advances, itcan be desirable for the displacement of the screw to increase as thescrew is driven into the bone/joint. This increased displacement can beaccomplished through an increase in the core diameter, an increase inthe thread displacement or both. The threads may or may not change alongthe length of the screw. For example, the thread thickness can increasefrom the screw tip to the screw head, the lateral extent of the threadscan increase from the tip to the head and/or the thread spacing candecrease from the tip to the head. Similarly, there may or may not be asecond set of threads between a first set of threads. With a screw thatprovides increasing displacement as the screw is inserted, the screwtightly grips as it is inserted into the sacroiliac joint.

Screws have a general structure with a tip and a top at the opposite endfrom the tip. The top may or may not include a head. However, the topgenerally comprises a flange to engage a driving tool. Threads spiralaround a core of the implant, although threads can be discontinuous insome embodiments without significantly changing their function. The tipmay or may not have cutting flutes. The core may or may not be porous,fenestrated, hollow and/or cannulated. In some embodiments, thecharacter of the screw changes along the length of the screw from thetip to the top. The character may or may not change uniformly ormonotonically, but on average the implant can be designed to maintain orincrease tension upon insertion.

In some embodiments, the improved implant for the sacroiliac joint is atapered screw. Tapered screws for sacroiliac immobilization/fusion arealso described in the present inventor's copending U.S. patentapplication Ser. No. 10/797,481, filed on Mar. 10, 2004, now U.S. Pat.No. 7,648,509, entitled “Sacroiliac Joint Immobilization,” incorporatedherein by reference. In general, the tapered screws can have taperedcores, tapered threads or both. While a taper can increase thedisplacement of the implant from the tip toward the head, otherparameters can similarly increase the thread displacement along thelength of the implant. For example, threads can have increaseddisplacement through an increase in thickness that correspondinglyincreases displacement resulting from increased thread volume.

The improved procedures and tools described herein can be used foreither open or closed procedures. In open procedures, the joint issurgically opened to visual observation of the joint. Once theboundaries of the joint are identified, the location for the implant canbe drilled out, such as with a powered mechanical reamer or drill. Careshould be taken to stay within the joint to avoid contacting any bloodvessels or nerves, of which there are significant members that passclose to the sacroiliac joint. The size of the reamer or drill bit canbe selected based on the size of the individual or other suitableparameters based on an examination of the patient.

An implant is then selected to distract and fuse the joint. As notedabove, implants of particular interest have structures that vary alongthe length of the implant to maintain or increase tension as the implantis inserted into the bore that is formed by the drilling. The implant isscrewed into the joint to provide the desired amount of distractionforces at its full placement. The selection of the screw can comprisethe use of a sizing element, which can be used with a wrench, such as atorque wrench, to select a correctly sized and characterized implant toscrew into the joint within a desired range of torque parameters.

In some embodiments, a sizing system can comprise a set of exchangeablesizing elements that have an outer shape approximating the outer shapeof the implants. The set of sizing elements can include, for example, anelement corresponding to each size of available implants. The sizingelements can be made from a material that can be easily sterilized, suchas stainless steel or other metal, so that the sizing elements can besterilized and reused. In some embodiments, a torque wrench can providea display output of the applied torque for monitoring by the health careprofessional or the wrench can be a torque limiting wrench that limitsthe amount of torque that can be applied so that the applied torque doesnot exceed an upper limit. Suitable torque limits for implant placementcan be in some embodiments from about 0.5 Newton-meters to about 12Newton-meters and in other embodiments form about 0.75 Newton-meters toabout 8 Newton-meters. Torque limiting wrenches are described further inU.S. Pat. No. 6,162,053 to Hollander, entitled “Analog Dental Wrench,”and U.S. Pat. No. 6,807,885 to Loper, entitled “Torque Limiting Wrenchfor an Ultrasonic Medical Device,” both of which are incorporated hereinby reference.

The sizing elements can be inserted into the prepared joint at a desiredamount of torque. If the sizing element holds at the selected torque,the correspondingly sized implant can be used following removal of thesizing element. In this way, the health professional can avoid theaccidental selection of an implant that is too small. If an implant isselected that is too small, the implant may strip out when it is beingimplanted, which would then require the subsequent use of a largerimplant. Since the implants generally cannot be reused, the initiallyselected implant that was too small can be wasted. Thus, the use of thesizing system can result in the waste of fewer implants since thecorrect size implant can be selected more accurately.

After completing the insertion of the implant, bone materials can beplaced into the joint to promote bone in growth that further supportsimmobilization. In particular, crushed bone material, demineralized bonematter, synthetic bone material or compositions or corresponding puttiescan be placed into the joint. Additionally or alternatively, bonemorphogenic protein or other similar bone growth stimulatingcompositions can be placed into the joint to stimulate bone growth toimmobilize the joint. In particular, it can be desirable to blendpowdered, natural or synthetic bone material with a bone growthcomposition, such as bone morphogenic protein, for placement into thejoint or other bone fracture to stimulate bone growth with the bonematerial as a foundation.

In the closed or less invasive procedures, a cannula can be placed intothe joint as guided by a pin or the like. The position of a pin to guidethe implant can be placed once other pins have been used to identify theboundaries of the joint. Various imaging approaches can be used to guidethe process of finding the boundaries of the joint without opening thejoint up for visual inspection. The cannula exposes a small opening tothe joint at the selected location of the implant placement. The cannulacan then guide the drilling and/or implant insertion steps in aprocedure that is less disruptive to the patient.

In general, approaches to the sacroiliac joint lack easily dissectibletissue planes that provide dissection between muscles or between nerves.Large adjacent nerves, such as the sciatic nerves, and arteries, such asthe iliac vessels, limit the approach to the joint and preclude certainaccess. The nearby vessels and nerves also greatly magnify the risk oferror. Similarly, the close location of the spine also provides limitsto access as well as further contributing to the risks.

The sacroiliac joint bone anatomy has a structure specifically for thenon-intuitive passage of force through the joint with the weight of thetorso transmitted to the hips. This transfer of forces generally takesplace whether seated or standing. The bone mass associated with thesacroiliac joint is limited and is not amenable to build up orreconstitution. Thus, procedures are generally designed to avoidsacrificing unnecessary amounts of bone support. In particular, drillingor impacting a bore within the joint should provide appropriate grippingof the implant without excessively weakening of the surrounding bone.

The bones around the joint exhibit complex coupled motions ofangulation, rotation and squirm. There is often little or no significantsliding or translation of surfaces over each other. Articular cartilageon one surface rests against fibrocartilage on the other surface, whichis unique in the body. In contrast, there are closely coupledcombinations with small degrees of relative motion of generally lessthan one degree in rotation or one millimeter in translation.Periarticular ligamentous structure combined with distant encompassingstructure controls the joint. At the same time, most muscles cross thejoint in a complex way. Most muscles cross several joints and/or diskspaces and transfer forces and balance forces between the plurality ofjoints at the same time. Also, many muscles that technically do notcross the joint help to control the joint.

Pain can result from the joint due to one or more pathologies.Congenital defects, such as smallness or malformation, can result inpain. Acquired laxity of the joint can result from pregnancy or due tocongenital conditions. Trauma, such as falls, can result from directincongruities that are secondary to pelvic or sacral fractures or fromligamentous disruption. Furthermore, inflammatory syndromes, such asseptic arthritis or rheumatic conditions can similarly result in pain inthe sacroiliac joint. Also, age results in an increasingly irregulartopography of each side of the joint with progressive changes in thesurface topography distributing unusual forces across the joint.Following performance of the procedure, the fused joint is fixed in amanner suitable to resist weight bearing stresses.

The procedures described herein are selected to improve the uniformityof results from sacroiliac fusion procedures. Similarly, the proceduresgenerally can be used with more consistent results by a medicalprofessional with less training and experience than procedures usingless well designed procedures. The implants are more specificallydesigned for use in the sacroiliac joint or for other orthopedicapplications that encounter bone structures of varying type during theprocedure. These implants yield more reproducible results relative toother implants, such as spinal implants, that are designed for othertypes of application, which can be inserted into the sacroiliac joint ina fusion procedure.

As noted above, the procedures and implants described here can be usedadvantageously for other orthopedic applications in which differenttypes of bone structures can be encountered, such as a hard outer boneand a soft inner bone. For example, the implants can be used for thereattachment of severed ligaments where the implant is directed into abone structure to perform the reattachment. In these applications, itcan be desirable to have an implant with changing structure along thelength of the implant.

Screw Structures and Materials

Screws of particular interest have changing parameters from the tip tothe head. These changing parameters can be selected to result in themaintenance or increase of tension upon insertion into properly preparedboned or joints. In some embodiments, the screws are tapered. Variousthread designs are appropriate to form desired screws that have desiredretention while providing desired amounts of dissection with spreadingforces, which are desirable for insertion into, for example, asacroiliac joint.

Referring to FIG. 1, an embodiment of an orthopedic screw 100 is shownschematically. Screw 100 comprises head 102, core 104, threads 106 andtip 108. Head 102 is optional. Head 102 has its conventional meaning asa terminal element having a lateral extent larger than the core adjacentthe head. Generally, head 102 comprises a driving tool engagement flange110, as shown in FIG. 2. Tool engagement flange 110 can have anyreasonable shape to engage a driving tool, such as a straight channel, across channel, a hexagonal depression or appropriate extensions. Asdescribed further below, a tool engagement flange can be located alongthe top surface of the core for embodiments lacking a head. In someembodiments, the tool engagement flange can extend significantly intothe core of the screw to provide an extended interface for engaging adrive tool.

Core 104 connects head 102 with tip 108 and supports threads 106. Thecore is the portion of the body of the screw without the threads. Asshown in FIG. 1, core 104 is tapered. An embodiment of a constantdiameter core 116 is shown in FIG. 3. Core 104 can be taperedindependent of the overall screw. In particular, if the core isgenerally cylindrical, the threads can have changing lateral extentalong the length of the screw to result in a tapered screw. Similarly,if the core is tapered, the lateral extent of the threads can beconstant to lead to the same taper for the screw, the lateral extent ofthe threads can change along the length of the screw to contributefurther to the taper of the screw or the threads can change along thelength of the screw to decrease or eliminate the overall taper of thescrew, as shown, for example, in FIG. 1.

Core 104 can be, for example, solid, hollow or cannulated. In thecannulated embodiments, a channel 118 ends through the entire length ofcore 120 such that the screw can be delivered over a pin or the like, asshown in FIGS. 4 and 5. Channel 118 would similarly extend through ahead or tip if present. Hollow cores can also be fenestrated to providefor bone in growth into the hollow core. For example, referring to FIG.6, core 124 has openings 126 into the hollow interior of core 124. Thetop of a hollow core screw can be reversibly openable, such as beingthreaded, such that bone material or other similar materials, can beinserted to promote bone in growth. Fenestrated spinal fusion cages thatcan be filed with bone material is described, for example, in U.S. Pat.No. 4,961,740 to Ray et al., entitled “V-Thread Fusion Cage and Methodof Fusing a Bone Joint,” and U.S. Pat. No. 5,669,909 to Zdeblick et al.,entitled “Interbody Fusion Device and Method for Restoration of NormalSpinal Anatomy,” both of which are incorporated herein by reference.

In general, threads 106 can have a variety of characteristics. In someembodiments, the threads have changing characteristics along the lengthof the implant. As shown in FIG. 1, threads 106 have a smaller lateralextent from the tip to the head, such that the edge of the threads forma generally cylindrical outer surface of the screw even though core 104has a diameter that increases toward the head. Some of the threadcharacteristics of particular interest are described in detail belowwith respect to some specific embodiments.

Referring to FIG. 1, tip 108 generally can be identified by an abruptchange in structure at a boundary 130. Tip 108 can have a point 132.Also, tip 108 can comprise cutting flutes 134 or the like to facilitateinsertion of the screw. If it is ambiguous whether or not a particularimplant has a separate tip, the 15 percent of the length of the implantaway from the head/top can be considered the tip adjacent the threadedcore. Tip 108 may or may not be threaded.

For implantation into a sacroiliac joint between the sacrum bone andiliac bone, it can be desirable to use an implant that is headless suchthat there is no head sticking up from the joint after the procedurethat can cause irritation to the patient. However, headless screws donot transfer axial forces to spreading forces when the top of the screwreaches the surface of bone. Thus, the screw should be designed toprovide spreading forces to distract the joint without the need for ahead to contact the bone surface.

An embodiment of a headless screw is shown in FIG. 7. Screw 140comprises core 142, threads 144 and drive flange 146, shown in FIG. 8.Drive flange 146 is located along top surface 148 at the top of core142. In this embodiment, core 142 is tapered such that the core has asmaller diameter near the tip of the screw and a larger diameter nearthe top of the screw adjacent the drive flange. Threads 144 spiralaround core 142 and have a roughly symmetrical shape relative to the topsurface of the thread and the bottom surface of the thread. Also,threads 144 have a roughly constant lateral extent from the core. Thelateral extent “L”, as shown in FIG. 7, is the distance from the core tothe edge of the thread. Thus, the diameter of the threads in screw 140increases from the tip to the head of the screw due to the taper of thecore and not due to a change in the lateral extent of the threads. Inalternative embodiments, the core can be tapered over a portion of thelength of the screw with a constant or counter tapered shape over otherportions of the screw while providing desired degrees of jointdistraction.

Another embodiment of a tapered bone screw is shown in FIG. 9. In thisembodiment, screw 150 comprises a core 152 and threads 154. The top 156of core 152 has a drive flange, which can be, for example, the same asshown in FIG. 8. In this embodiment, core 152 has an approximatelyconstant diameter along the length of the screw extending along the axisof the screw. However, the lateral extent of the threads increases fromthe tip to the top of the screw. Thus, the diameter of the threads andthe overall screw diameter correspondingly increase as a result of theincreased thread lateral extent even though the core has a constantdiameter. Threads 154 have an asymmetric shape with a flatter topsurface relative to a more angled lower surface. Asymmetric threads arediscussed in more detail below. In alternative embodiments, the core istapered and the lateral extent of the threads changes such that thereare two contributions to the overall taper of the screw.

Another embodiment of a tapered bone screw is shown in FIG. 10. Screw160 is also a headless screw comprising a core 162 and threads 164. Topsurface 166 of core 162 has a driver flange, which can be, for example,the same as shown in FIG. 8. Core 162 has a taper in this embodiment,although in other embodiments the core can have a constant diameter. Inthis embodiment, threads 164 have two segments 166, 168 with differentpitch. In particular, threads 168 have adjacent threads closer to eachother than threads 166. In this embodiment, the thread pitch change isrelatively abrupt, although in other embodiments the thread pitch canchange gradually. Similarly, the other embodiments, the threads can havethree or more sections with different pitch from each other.

An embodiment of a tapered bone screw 180 is shown in FIG. 11 in whichthe screw has two sets of interwoven, coaxial threads. Specifically,screw 180 comprises a core 182, first threads 184 and second threads186. Second threads 186 spiral around the core between the threads offirst threads 184. The properties of the two sets of threads can beselected as desired. In general, two sets of threads can be combinedwith other screw features described herein, such as headed or headlessscrews, tapered cores or cylindrical cores, etc.

In general, for appropriate embodiments the screws should haveappropriate dimensions for insertion into the sacroiliac joint betweenthe sacrum bone and iliac bone. The screw should provide desiredimmobilization of the joint without damaging the surrounding bone. Forembodiments with a screw head the head can have any reasonable dimensionbased on the overall screw dimensions.

For insertion into the sacroiliac joint, the length should be selectedsuch that the implanted screw, except possibly for an optional screwhead should be contained with in the joint. For a typical adult human,the screws then can have a length from about 10 millimeters (mm) toabout 45 mm, and in other embodiments from about 15 mm to about 35 mm.For other orthopedic applications, suitable lengths of the screwgenerally range from about 10 mm to about 80 mm. A person of ordinaryskill in the art will recognize that other ranges of screw lengthswithin the explicit ranges above are contemplated and are within thescope of the present disclosure.

Similarly, for insertions within a sacroiliac joint, the screw shouldhave a diameter that is consistent with distracting the bone withoutbeing too large such that the bone is damaged through its insertion. Fora typical adult human, appropriate screw would have an average diameterfrom about 6 mm to about 28 mm, and in other embodiments from about 8 mmto about 25 mm. A person of ordinary skill in the art will recognizethat additional ranges of diameters within the explicit ranges above arecontemplated and are within the scope of the present disclosure. If thescrew is tapered, the leading diameter and trailing diameter correspondwith the amount of taper and the average diameter.

In general, the screw taper can be determined as the angle of the screwedge relative to the screw axis. In general, the taper can be at leastabout 1 degree, in further embodiments at least about 2 degrees, inother embodiments from about 3 degrees to about 12 degrees, and inadditional embodiments from about 3.5 degrees to about 10 degrees. Asnoted above, the taper can result from a core taper, a variation in thethreads of the lateral extent or both. The range of core tapers cangenerally range over the same ranges of angles given above for theoverall taper of the screw. Of course, a taper does not need to belinear, so that the surface of the screw can be curved. For curvedtapers, the angle can be estimated from threads adjacent the tip and thetop to provide a reasonable estimate of the angle of the overall taper.

In general, the threads can have several parameters to characterize thenature of the threads. For example, the thickness of the thread can beevaluated at the point half way from the edge of the thread to the core.This thickness “T” is noted in FIG. 7 for reference. The thickness canbe related to the sharpness of the thread. The edge of the thread can besharp, but generally it is desirable for the edge of the thread to berounded. As shown in FIG. 7, the threads meet the core along smoothcurves. Smooth transitions at the edges of the elements avoid theundesirable concentration of forces along the bone that can result in apoor interface between the bone and screw. The cross sectional shape ofthe threads can be approximately symmetrical or in other embodimentsasymmetrical relative to the top and the bottom of the threads.

The top of the thread is oriented toward the top of the screw while thebottom of the thread is oriented toward the tip of the screw. Theleading and trailing edges generally have different functions so that itmay be desirable for these surfaces to have different shapes from eachother. For example, the top thread surface may push outward on the bonewhile the lower surface may cup or compress the bone longitudinally asit pulls the screw deeper.

The thread dimensions can be selected to achieve the desired distractionand gripping properties of the screw upon implantation. The averagelateral extent of the screw can be 0.25 to 2.5 millimeters and in otherembodiments from about 0.4 to about 2.0 millimeters. In someembodiments, the lateral extent of the thread tapers along the length ofthe screw with a greater lateral extent of the thread near toward thetop of the screw, such as shown in FIG. 9. For these embodiments, thelateral extent of the tapered threads can be at least about 0.1 mm andin further embodiments at least about 0.25 for the smaller threads, andthe larger lateral extent of the threads of the screw can be no morethan about 3.5 mm and in further embodiments no more than about 3 mm. Insome embodiments, the variation in the lateral extent of the threads ismonotonic along the length of the screw optionally excluding the lastturn of the threads at the top and/or at the tip.

The average pitch of the threads can be generally from about 1 mm perturn to about 4 mm per turn, and in further embodiments from about 1.5mm per turn to about 3.5 mm per turn. As noted above, the pitch of thethreads can be constant over the length of the screw or the pitch of thethreads can change over the length of the screw or a portion thereof. Ingeneral, it is desirable for the threads to have smooth surfaces at theedge of the threads as well as at the meeting of the threads with thecore. Thus, while the threads can be sharp, smooth surfaces of thethreads can avoid discontinuities that can result in undesirableconcentration of forces. However, in some embodiments, discontinuousthread surfaces can result in a desirable concentration of forces.

In general, the implants/screws can be formed from any suitablebiocompatible material, which is non-toxic. The material can bebiologically effectively inert or can impart specific desired biologicaleffects, such as through the elution of bone morphogenic protein.Suitable biocompatible materials can include, for example, metals, suchas stainless steel, tantalum and titanium, rigid polymers, such aspolycarbonates and polyetheretherketone (PEEK), ceramics, such asalumina, or composites, such as carbon composites or carbon fibercomposites. In some embodiments, the screws can comprise a bioresorbablepolymer, such as poly(hydroxyacids), poly(epsilon-caprolactone),polylactic acid, polyglycolic acid, poly(dimethyl glycolic acid),copolymers thereof and mixtures thereof. The screws can be formed, forexample, using conventional machining, molding or the like. The screw orits surface can be porous. For example, porous tantalum is commerciallyavailable for forming the screw. In addition, synthetic bone materialsand/or sterile bone materials, either allograft or xenograft materials,can be used to form the implantation elements. Suitable synthetic bonematerial includes, for example, coral and calcium compositions, such ashydroxyapatite, calcium phosphate and calcium sulfate.

In some embodiments, the implant can be formed from a bio-resorbablepolymer a natural or synthetic bone material or a combination thereofand a bioactive agent that stimulates bone development, such as BMP. TheBMP can be blended with the material prior to molding, casting orotherwise formed into the implant or portion thereof. Generally, if aportion of the implant is formed from the BMP blended with bioresorbablypolymer or bone material, this portion can be a support portion, i.e., aportion that provides mechanical integrity to the implant. Inappropriate embodiments, as the resorbable polymer biodegrades, bonereplaces the implant material. Similarly, for implants formed from thebone material, the implant becomes incorporated into the new bone thatforms as a result of the bioactive agent.

Optionally, a bioactive agent can be coated on the surface of theimmobilization element. To coat the immobilization device with thebioactive agent, the device can be dipped in a composition comprisingthe bioactive agent, sprayed with a composition comprising the bioactiveagent, painted with the bioactive agent, and/or coated with otherprocesses, such as those generally known in the art. If the coatingcomposition comprises a solvent, the solvent can be allowed to evaporateafter applying the coating composition. The bioactive agent can beapplied alone as a coating composition or with another agent to controlthe elution of the agent. The agent can be applied from a solution witha solvent that can evaporate following the application of the coatingsolution. Also, the bioactive agent can be combined with a controlrelease agent, such as a biodegradable polymer that gradually releasesthe bioactive agent as the polymer degrades within the patient.Biocompatible, biodegradable polymers are known in the art, such aspolylactic acid, poly(glycolic acid) and copolymers and mixturesthereof. A binder may or may not be included to control the elution fromthe coating. Furthermore, the bioactive agent can be injected orotherwise delivered in the vicinity of the immobilization device. Thebioactive agent can be combined with a suitable biocompatible carrier,such as commercially available buffered saline or glycerol.

Suitable biologically active agents include, for example, bonemorphogenic protein (BMP) and cytokines. BMP mediates the formation andhealing of bone, cartilage, tendon and other bone related tissues. Onehuman BMP polypeptide is described in detail in Published U.S. PatentApplication Serial Number 2003/0032098 to Young et al., entitled “BoneMorphogenic Protein,” incorporated herein by reference. Suitablecytokines include, for example, human chemokine alpha 2, which iseffective to stimulate bone marrow growth. A human cytokine, humanchemokine alpha 2, is described in U.S. Pat. No. 6,479,633 to Ni et al.,entitled “Chemokine Alpha 2,” incorporated herein by reference.

Sacroiliac Joint Fusion Procedure with Distracting Screws

The sacroiliac joint can be successfully fused using a distractingimplant that is inserted into the joint between the sacrum bone and theiliac bone with a screw design that maintains or increases tension asthe screw is tightened. In general, the joint is prepared by selectingthe location of the implant within the joint and exposing the areaeither through an open procedure or through a cannula for a lessinvasive procedure. The location selected for the implant can be drilledto prepare the joint for the implant. Following implantation of thescrew, filler material can be placed within the joint to furtherstabilize the joint and promote bone in growth. Additionally oralternatively, bioactive compositions can be used to stimulate bone ingrowth.

The appropriate approach to the sacroiliac joint for the insertion of animplant is from the patient's back, at or just above the buttocks andslightly displaced form the patient's center line running along theirspine. The approach is angled outward back to front. The two openingsinto the joint are displaced with one accessible from the left and theother from the right. Generally, the health care professional selectsone side or the other for immobilization based on an examination of thepatient, although in some embodiments, at least one implant is placed oneach side of the patient.

The selected side of the joint can be accessed with an open procedure orthrough a less invasive procedure. In the open procedure, a significantincision is made to expose the joint, and the exposed area is clearedout for desired exposure to the joint. In contrast, for the lessinvasive procedure, a cannula can be used to form an opening to thejoint. Pins can be used to locate the limits of the joint as well as alocation for the implant placement. Visualization techniques, such asx-ray visualization, can be used to facilitate pin placement. Drillingand implant placement can be performed through the cannula. Closedprocedures for immobilization of the sacroiliac joint through placementof an implant into the joint is described further in Applicant'scopending U.S. patent application Ser. No. 10/797,481 filed on Mar. 10,2004, now U.S. Pat. No. 7,648,509, entitled “Sacroiliac JointImmobilization,” incorporated herein by reference.

Referring to FIG. 12, portion of the sacroiliac joint is shown. As notedabove, the sacroiliac joint 200 is located between the sacrum 202 at thebase of the spine and the ilium 204, the upper bone of the pelvis. Asshown in FIG. 12, various ligaments 206 support the joint. Referring toFIG. 13, walking and other movement apply torque on the sacroiliac joint200. As shown in FIG. 13, sacroiliac joint 200 is shown with phantomlines between the spine 208 and the pelvis 110. This torque on thesacroiliac joint can result in pain if there is injury or disease.

Once the selected section of the joint is exposed with an open or a lessinvasive approach, the site can be prepared using a drill or reamer orimpactor. Commercial orthopedic drills are available with a selectablerange of drill bits. A powered impactor that can be adapted for theinsertion of a sizing element is discussed in U.S. Pat. No. 7,001,393 toSchwenke et al., entitled “Servo-Controlled Impacting Device ForOrthopedic Implants,” incorporated herein by reference. In addition,impaction of the joint can be performed using a manual or power drilloperated with the drill bit rotating backwards so that bone is notremoved, but the joint is distracted through impaction by the rotatingdrill bit in preparation for the placement of an implant. Referring toFIG. 14, a site 220 is identified within the sacroiliac joint 222between the sacrum bone 224 and the iliac bone 226. A drill bit 228 isshown in FIG. 14 positioned above the drill site 220. During thedrilling process, care should be taken not to drill past the joint toavoid injuring any blood vessels or ligaments. The hole can be drilledto have a smaller dimension than the average dimension of the screw sothat the screw firmly anchors in place. If the screw has a pointed tip,the drilled bore can have a diameter approximately equal to the smallerdiameter of threads along a tapered core.

Referring to FIG. 15, once bore 230 is drilled into the joint areabetween sacrum bone 224 and ilium bone 226, a screw 232 can be screwedinto bore 230. As described herein, in some embodiments, screw 232 canbe selected to distract the joint during placement. The distractioninvolves the slight movement away of sacrum bone 224 from ilium bone 226while stabilizing the joint. As shown FIGS. 14 and 15, an implant isinserted into the left sacroiliac joint. In other embodiments, animplant is inserted into right sacroiliac joint 234, or separateimplants are placed into both the left and right sacroiliac joints. Thesacroiliac joint with the representative implant is shown in FIGS. 16and 17 along with additional stabilizing material 240.

Once the screw/implant is inserted into the joint, additionalstabilizing material can be placed into the joint. This stabilizingmaterial can be selected to promote bone growth into the joint tofurther contribute to bone immobilization. Suitable materials include,for example, synthetic bone materials and/or sterile bone materials,either allograft or xenograft materials. Suitable synthetic bonematerial includes, for example, coral and calcium compositions, such ashydroxyapatite, calcium phosphate and calcium sulfate. The bone materialcan be placed into the joint as a powder. Suitable material includes,for example, demineralized bone powder, which is commercially available.Gels and putty of demineralized bone powder suspended in glycerol arealso commercially available.

Suitable biologically active agents include, for example, bonemorphogenic protein (BMP) and suitable cytokines. BMP is involved information and healing of bone related tissue, including bone, cartilageand tendon. Suitable cytokines include, for example, human chemokinealpha 2, which is effective to stimulate bone marrow growth.Furthermore, the bioactive agent can be injected or otherwise deliveredin the vicinity of the immobilization device.

The biologically active agents can be coated onto an implant fordelivery. In some embodiments, it has been found that desirable resultsare obtained through a blend of biologically active agent, such as BMP,and bone powder, such as demineralized bone powder or crushed bonematerial, although synthetic materials can be used similarly. Thematerial can be blended and then deposited into the joint, or thematerials can be layered into the joint.

The embodiments above are intended to be illustrative and not limiting.Additional embodiments are within the claims. Although the presentinvention has been described with reference to particular embodiments,workers skilled in the art will recognize that changes may be made inform and detail without departing from the spirit and scope of theinvention. The incorporations by reference above are intended toincorporate the full disclosures of the references to the extent thatthe incorporated subject matter is not inconsistent with the explicitdisclosure herein, which will not be altered by any incorporation byreference, as well as to incorporate the disclosures with respect to thespecific issues referenced in the incorporation.

What is claimed is:
 1. A method of stabilizing a sacroiliac joint withan implant, the method comprising: drilling a bore between the opposingbones of the sacroiliac joint; and driving an implant into the borebetween opposing bones to distract the joint without piercing entirelythrough the bones of the joint; wherein the implant comprises metal, atapered shaft comprising a core and a thread extending along the core,which is hollow; wherein the shaft comprises a fenestration openingthrough a side into the core; and wherein the drilling and driving stepsare performed through a cannula.
 2. The method of claim 1 wherein atleast a portion of the thread is asymmetrical with respect to the shapeof a top surface and a bottom surface.
 3. The method of claim 1 whereinthe drilling and driving steps are performed over a pin.
 4. The methodof claim 3 wherein positioning of the pin is facilitated with imaging.5. The method of claim 1 further comprising evaluating the joint using asizing element.
 6. The method of claim 5 further comprising selecting asize of the implant based on evaluation of the joint with the sizingelement.
 7. The method of claim 1 wherein an edge of the thread is sharpalong a length of the thread from the head to the tip.
 8. The method ofclaim 1 wherein the implant comprises a head at a first end of the shaftand the core extends from the head, the head having a lateral extent nosmaller than the core adjacent the head and the top surface of the headcomprises a driver engagement element to engage a driving tool.
 9. Themethod of claim 1 wherein implant shaft has a porous surface.
 10. Themethod of claim 1 wherein bone material is placed within thefenestrations prior to the driving of the implant into the joint.
 11. Amethod of stabilizing a sacroiliac joint with an implant, the methodcomprising: drilling a bore between the opposing bones of the sacroiliacjoint; and driving an implant into the bore between opposing bones todistract the joint without piercing entirely through the bones of thejoint; wherein the implant comprises metal, a tapered shaft thatcomprises a core and a thread extending along the core, wherein at leasta portion of the thread is asymmetrical with respect to the shape of atop surface and a bottom surface; wherein the implant along the shaft issolid and un-fenestrated with a porous surface.
 12. The method of claim11 wherein the drilling and driving steps are performed through acannula.
 13. The method of claim 12 wherein the drilling and drivingsteps are performed over a pin.
 14. The method of claim 13 whereinpositioning of the pin is facilitated with imaging.
 15. The method ofclaim 12 further comprising evaluating the joint using a sizing element.16. The method of claim 15 further comprising selecting a size of theimplant based on evaluation of the joint with the sizing element. 17.The method of claim 11 wherein an edge of the thread is sharp along alength of the thread from the head to the tip.
 18. The method of claim11 wherein the a head at a first end of the shaft and head is a terminalelement having a lateral extent larger than the core adjacent the headand the top surface of the head comprises a driver engagement element toengage a driving tool.
 19. The method of claim 11 wherein the topsurface of the thread is flatter relative to a curved lower surface ofthe thread.
 20. The method of claim 11 wherein the core has a tipcomprising a cutting flute;